Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns

Nestlé

Status: Completed

Conditions: Infant Nutritional Physiological Phenomena; Infant Formula

Treatments: Other: NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format

Study type: Observational

Funder types: Industry

Identifiers

NCT05097924

21.07.INF

Details and patient eligibility

About

Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study

Enrollment: 150 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent has been obtained from both parents or a legally acceptable representative (LAR).
• Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g.
• Parent(s) must have independently elected, before enrollment, to formula feed.
• Infant age ≤ 24 hours after birth.
• Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.

Exclusion criteria

• Infant is exclusively breastfed.
• Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders.
• Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
• Conditions that require infant feedings other than those specified in the protocol.
• Infant is currently participating in another interventional clinical trial that impacts study outcomes.